Joe Biden (Credit: Doug Mills/The New York Times/Bloomberg via Getty Images)

Biden’s bud­get wish list: Re­store the CDC, build a new NIH re­search cen­ter, pump in bil­lions to end the opi­oid and HIV epi­demics

Pres­i­dent Joe Biden’s first bud­get re­quest (Con­gress is the ul­ti­mate de­cider on bud­gets) for FY 2022 in­cludes a mas­sive in­flux of funds to the CDC, plans to launch a new $6.5 bil­lion re­search cen­ter with­in the NIH, as well as al­most $11 bil­lion to end the opi­oid epi­dem­ic and an­oth­er $670 mil­lion to ag­gres­sive­ly re­duce new HIV cas­es.

But de­tails on what ex­act­ly this new $6.5 bil­lion, DARPA-like, NIH-based cen­ter, to be known as Ad­vanced Re­search Pro­jects Agency for Health (ARPA-H), will re­search re­main to be seen. Biden’s bud­get re­quest on­ly said the cen­ter will ini­tial­ly fo­cus on a wide range of dis­eases that oth­er NIH cen­ters typ­i­cal­ly work on.

“With an ini­tial fo­cus on can­cer and oth­er dis­eases such as di­a­betes and Alzheimer’s, this ma­jor in­vest­ment in Fed­er­al re­search and de­vel­op­ment would dri­ve trans­for­ma­tion­al in­no­va­tion in health re­search and speed ap­pli­ca­tion and im­ple­men­ta­tion of health break­throughs,” the re­quest says.

At $6.5 bil­lion, the cen­ter will have about as much an­nu­al fund­ing as the Na­tion­al Can­cer In­sti­tute re­ceived in FY 2021. The funds are part of a $9 bil­lion re­quest­ed in­crease for NIH over­all.

Fol­low­ing the Trump ad­min­is­tra­tion’s sidelin­ing of the CDC, Biden’s dis­cre­tionary re­quest al­so in­cludes $8.7 bil­lion for the agency — a jump of $1.6 bil­lion over the 2021 en­act­ed lev­el, the largest bud­get au­thor­i­ty in­crease in near­ly two decades — to “re­store ca­pac­i­ty at the world’s pre­em­i­nent pub­lic health agency.” The new funds will help to mod­ern­ize pub­lic health da­ta col­lec­tion, train new epi­demi­ol­o­gists and oth­er pub­lic health ex­perts, and build in­ter­na­tion­al ca­pac­i­ty to de­tect, pre­pare for, and re­spond to glob­al pub­lic health threats.

In ad­di­tion, Biden al­so seeks an in­vest­ment of $10.7 bil­lion, an in­crease of $3.9 bil­lion over the 2021 en­act­ed lev­el, to sup­port re­search, pre­ven­tion, treat­ment, and re­cov­ery sup­port ser­vices re­lat­ed to the opi­oid epi­dem­ic. The ad­min­is­tra­tion said those funds will in­clude tar­get­ed in­vest­ments to sup­port those with unique needs, in­clud­ing Na­tive Amer­i­cans, old­er Amer­i­cans, and rur­al com­mu­ni­ties.

An­oth­er $670 mil­lion in the pro­pos­al for HHS will aim to help ac­cel­er­ate and strength­en ef­forts to end the HIV/AIDS epi­dem­ic in the US by in­creas­ing ac­cess to treat­ment, ex­pand­ing the use of pre-ex­po­sure pro­phy­lax­is, and im­prov­ing eq­ui­table ac­cess to ser­vices and sup­port.

Over­all, the pres­i­dent’s 2022 dis­cre­tionary re­quest in­cludes $131.7 bil­lion for HHS, which is a $25 bil­lion or 24% in­crease from 2021.

No­tably ab­sent in the bud­get re­quest is any de­tail re­lat­ed to the FDA’s bud­get. The re­quest mere­ly says the ad­min­is­tra­tion “would make in­vest­ments to en­hance FDA’s or­ga­ni­za­tion­al ca­pac­i­ty.” The FDA por­tion of the pres­i­dent’s full re­quest will like­ly in­clude more de­tail.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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